Shein-Chung Chow 
Biosimilars [PDF ebook] 
Design and Analysis of Follow-on Biologics

As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator”s biologic products. But scientific challenges remain due to the complexity of both the manuf